Headache MigraineNCT06398353
Investigating the Impact of Acupuncture on the Quality of Life of Primitive Headaches Patients
A study testing Real acupuncture in people with Headache Migraine, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Primary headache is one of the most common neurological diseases in modern society, which seriously affects the patient's quality of life. Although the use of painkillers can alleviate primary headache symptoms, it may also cause drug dependence. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Headache Migraine
- What is being tested?
- Real acupuncture
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- 31 Jan 2024to 31 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Willing to sign a written subject consent form
- Male or female over 18 years old
- Those who have headaches (for example: dizziness, heavy head, dizziness, head fullness, migraine), those who have headaches more than twice a week, and whose NRS score is ˃ 4.
- Headache definition: Headache symptoms are classified according to the ICHD-3 headache classification of the International Headache Organization, and are mainly primary headaches.
- Dr. Chang ,Y.-J. and Dr. Yang ,C.-C. help to exclude headache patients with the following exclusion conditions to reduce the risk to subjects.
- Exclusin Criteria
Show all 15Show fewer
- Pregnant women
- Various acute and chronic infectious diseases, various skin ulcers, sores, burns, etc.
- The patient has injuries to the radial artery or wrist, or has steel nails, plates, or fractures.
- Various types of headaches related to anatomical structural lesions
- Headaches associated with taking or withdrawing from substances (drugs, food, or other chemicals)
- Headaches related to non-head infections and metabolic diseases
- People with painful cranial neuropathy, other facial pain and other headaches
- People with secondary headaches according to ICHD-3 beta
- Other patients who have been evaluated by physicians as not suitable for inclusion in the evaluation.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Chang Gung Memorial Hospital
Taoyuan, Select A State, 333323
Chien-Chung Yang, 03-3196200 ext. 2610, r55161@cgmh.org.tw
Chumgyili Li, 03-2118800 ext. 5593, chungyili@mail.cgu.edu.tw
About this study
Primary headache is one of the most common neurological diseases in modern society, which seriously affects the patient's quality of life. Although the use of painkillers can alleviate primary headache symptoms, it may also cause drug dependence. Therefore, alternative therapies that do not rely on drugs have attracted increasing attention in recent years. Among them, acupuncture has been partially recognized by the public as an effective treatment for primary headaches. However, there is currently no scientific evidence that acupuncture is effective for primary headaches. The purpose of this project is to verify the effect of acupuncture in treating primary headaches. This study has three sub-projects:
Subproject 2 explores the impact of acupuncture on headache severity and quality of life in patients with primary headaches. We evaluate the quality of life before and after acupuncture treatment through professional questionnaires, including the Numerical rating scale (NRS), headache diary, depression, anxiety and stress scale (DASS-21), health quality of life measurement questionnaire, Migraine Disability Assessment Scale and SF-36 Taiwan version. Finally, these data will be combined with the pulseway analysis from the results of sub-project 1 to provide a comprehensive way to evaluate the treatment effect.
Read the detailed description
In this study, 120 subjects who already suffered from headache symptoms (such as dizziness, heavy head, lightheadedness, head fullness, migraine) were treated with acupuncture at acupuncture points, and the pulse diagnosis instrument was used to capture the subjects' symptoms during acupuncture. The pulse waves before and after are collected, compared and analyzed to complete this test.
After the subjects are accepted, they will go to the Acupuncture and Traumatology Department of the Department of Traditional Chinese Medicine of Chang Gung Memorial Hospital (Taoyuan Branch) at an agreed time for health education and filling out questionnaires. After filling out the questionnaire, participants can reserve a time for the test.
One person is tested each time, and each test lasts 70-80 minutes. Pulse waves are collected for 20 minutes before and after the test. The acupuncture treatment plan for each subject in this study was based on traditional Chinese medicine theory and published literature. The acupuncture points selected were bilateral Cuanzhu, Taiyang, Tianzhu, Fengchi, Baihui, Hegu, Neiting, Zusanli, Waiguan, and Zulin. Qi, Houxi, Shenmai, Taichong. The doctor will select the above 4-6 acupoints according to the disease. It is divided into an acupuncture group and a sham acupuncture group. Before the experiment, first fill out the questionnaire. This trial is divided into an acupuncture group and a sham acupuncture group. A crossover design is adopted. 50% of the subjects will be assigned to the acupuncture group first. Then they will be connected to the sham acupuncture group, and the other 50% of the subjects will be assigned to the sham acupuncture group first and then the acupuncture group. Each group will last for two weeks, and acupuncture will be performed twice a week at the set acupuncture points. The first group of acupuncture will end. , will be interrupted for two weeks, and then another set of tests will be conducted, and then the patient will go to Chang Gung Memorial Hospital Taoyuan Branch for the final scale and quality of life questionnaire. The total trial period was eight weeks.
While undergoing the test, try to avoid taking Chinese and Western medicines and alcoholic beverages to avoid interfering with the study. (If participants usually take antihypertensive drugs and heart drugs, participants can continue to take them.) After the test, participants should drink more warm water and get enough rest. Do not take a shower or touch or drink cold things.
- Conditions
- Headache Migraine
- Being tested
- Real acupuncture, Sham acupuncture
- Keywords
- Headache, Migraine
- Medical subject headings
- Migraine Disorders, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real acupunctureOther
Real acupuncture twice a week for two weeks
Sham acupunctureOther
Sham acupuncture twice a week for two weeks
| Study group | Role | What they receive |
|---|---|---|
| acupuncture | Experimental | Not described Receives: Other: Real acupuncture; Other: Sham acupuncture |
| sham acupuncture | Sham comparator | Not described Receives: Other: Real acupuncture; Other: Sham acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical rating scale
Numerical rating scale (NRS) is the most commonly used pain intensity assessment tool at home and abroad. A straight line that is actually 10 centimeters, marked with "0" on the far left and "10" on the far right. Explain to the patient that "0" means no pain and "10" means very painful. The pain level increases from left to right, so that the patient can Draw vertically with a pen a few centimeters where the pain feels and record it in centimeters. You can also simply explain to the patient orally the meaning represented by "0" to "10" and let the patient rate it (verbal rating).
Measured: 2 minutes
The Depression, Anxiety and Stress Scale (DASS-21),
The Depression, Anxiety and Stress Scale (DASS-21), also known as the "Self-Rating Emotion Scale" is a self-report scale that effectively assesses depression, anxiety and stress levels of the general population; it has 21 questions in total and takes time About 5 minutes. Although this scale cannot replace professional clinical diagnosis, nor can it be used as a basis for diagnosis alone, it has a significant screening effect on minor mental health problems.
Measured: 7minutes
Europe health-related quality of life questionnaire 5 dimensions (EQ-5D)
Europe health-related quality of life questionnaire 5 dimensions (EQ-5D) is a preference-based health life quality measurement tool. It includes 5 self-classifier questions and 0 - Two parts including a 100-point self-assessment scale for current health status.
Measured: 7minutes
The headache diary
The headache diary is to record your own headache diary every day, which can make it easier to communicate with the doctor about your pain condition and help the doctor treat primary headaches.
Measured: 20minutes
Migraine Disability Assessment Questionnaire (MIDAs)
Migraine Disability Assessment Questionnaire (MIDAs) In 1999, Stewart and Lipton proposed the Migraine Disability Assessment Questionnaire (MIDAs). This scale mainly consists of five questions, asking the patient to recall the impact of migraine on schoolwork or work, household affairs, and family, social or leisure activities during the past three months. This questionnaire is also used in Japan, Upper Turkey, Italy and other countries because it is simple and easy to use and has good reliability, validity and objectivity evaluation.
Measured: 7minutes
The Taiwan Short Form 36 Health Scale (SF-36)
The Taiwan Short Form 36 Health Scale (SF-36) is a widely used health-related quality of life questionnaire and is also used by people with different cultural backgrounds. Research results show that SF36 has been proven to have good reliability and validity regardless of the diagnosis, age, and gender of the test subjects, and it can also sensitively detect changes before and after treatment without falling. Therefore, this study uses SF36 as the outcome measurement tool for this study.
Measured: 20minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2024
- Study start31 Jan 2024
- Primary completion1 Jun 2027 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Headache MigraineStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chien-Chung YANG, Study director, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06398353
- Sponsor's protocol ID
- 232
- Status last verified
- Jan 2024
- First submitted
- 18 Mar 2024
- Last updated
- 7 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Impact of Acupuncture on the Quality of Life of Primitive Headaches Patients
- ClinicalTrials.gov ID
- NCT06398353
- Acronym / sponsor ID
- 232
- Conditions
- Headache Migraine
- Keywords
- Headache, Migraine
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 31 Jan 2024 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 3 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary headache is one of the most common neurological diseases in modern society, which seriously affects the patient's quality of life. Although the use of painkillers can alleviate primary headache symptoms, it may also cause drug dependence. Therefore, alternative therapies that do not rely on drugs have attracted increasing attention in recent years. Among them, acupuncture has been partially recognized by the public as an effective treatment for primary headaches. However, there is currently no scientific evidence that acupuncture is effective for primary headaches. The purpose of this project is to verify the effect of acupuncture in treating primary headaches. This study has three sub-projects:
Subproject 2 explores the impact of acupuncture on headache severity and quality of life in patients with primary headaches. We evaluate the quality of life before and after acupuncture treatment through professional questionnaires, including the Numerical rating scale (NRS), headache diary, depression, anxiety and stress scale (DASS-21), health quality of life measurement questionnaire, Migraine Disability Assessment Scale and SF-36 Taiwan version. Finally, these data will be combined with the pulseway analysis from the results of sub-project 1 to provide a comprehensive way to evaluate the treatment effect.
Detailed description
In this study, 120 subjects who already suffered from headache symptoms (such as dizziness, heavy head, lightheadedness, head fullness, migraine) were treated with acupuncture at acupuncture points, and the pulse diagnosis instrument was used to capture the subjects' symptoms during acupuncture. The pulse waves before and after are collected, compared and analyzed to complete this test.
After the subjects are accepted, they will go to the Acupuncture and Traumatology Department of the Department of Traditional Chinese Medicine of Chang Gung Memorial Hospital (Taoyuan Branch) at an agreed time for health education and filling out questionnaires. After filling out the questionnaire, participants can reserve a time for the test.
One person is tested each time, and each test lasts 70-80 minutes. Pulse waves are collected for 20 minutes before and after the test. The acupuncture treatment plan for each subject in this study was based on traditional Chinese medicine theory and published literature. The acupuncture points selected were bilateral Cuanzhu, Taiyang, Tianzhu, Fengchi, Baihui, Hegu, Neiting, Zusanli, Waiguan, and Zulin. Qi, Houxi, Shenmai, Taichong. The doctor will select the above 4-6 acupoints according to the disease. It is divided into an acupuncture group and a sham acupuncture group. Before the experiment, first fill out the questionnaire. This trial is divided into an acupuncture group and a sham acupuncture group. A crossover design is adopted. 50% of the subjects will be assigned to the acupuncture group first. Then they will be connected to the sham acupuncture group, and the other 50% of the subjects will be assigned to the sham acupuncture group first and then the acupuncture group. Each group will last for two weeks, and acupuncture will be performed twice a week at the set acupuncture points. The first group of acupuncture will end. , will be interrupted for two weeks, and then another set of tests will be conducted, and then the patient will go to Chang Gung Memorial Hospital Taoyuan Branch for the final scale and quality of life questionnaire. The total trial period was eight weeks.
While undergoing the test, try to avoid taking Chinese and Western medicines and alcoholic beverages to avoid interfering with the study. (If participants usually take antihypertensive drugs and heart drugs, participants can continue to take them.) After the test, participants should drink more warm water and get enough rest. Do not take a shower or touch or drink cold things.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| acupuncture | Experimental | Other: Real acupuncture, Other: Sham acupuncture |
| sham acupuncture | Sham comparator | Other: Real acupuncture, Other: Sham acupuncture |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Willing to sign a written subject consent form
- Male or female over 18 years old
- Those who have headaches (for example: dizziness, heavy head, dizziness, head fullness, migraine), those who have headaches more than twice a week, and whose NRS score is ˃ 4.
- Headache definition: Headache symptoms are classified according to the ICHD-3 headache classification of the International Headache Organization, and are mainly primary headaches.
- Dr. Chang ,Y.-J. and Dr. Yang ,C.-C. help to exclude headache patients with the following exclusion conditions to reduce the risk to subjects.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Real acupunctureReal acupuncture twice a week for two weeks | Other | acupuncture, sham acupuncture |
| Sham acupunctureSham acupuncture twice a week for two weeks | Other | acupuncture, sham acupuncture |
Primary outcome
Numerical rating scale
Time frame: 2 minutes
Numerical rating scale (NRS) is the most commonly used pain intensity assessment tool at home and abroad. A straight line that is actually 10 centimeters, marked with "0" on the far left and "10" on the far right. Explain to the patient that "0" means no pain and "10" means very painful. The pain level increases from left to right, so that the patient can Draw vertically with a pen a few centimeters where the pain feels and record it in centimeters. You can also simply explain to the patient orally the meaning represented by "0" to "10" and let the patient rate it (verbal rating).
The Depression, Anxiety and Stress Scale (DASS-21),
Time frame: 7minutes
The Depression, Anxiety and Stress Scale (DASS-21), also known as the "Self-Rating Emotion Scale" is a self-report scale that effectively assesses depression, anxiety and stress levels of the general population; it has 21 questions in total and takes time About 5 minutes. Although this scale cannot replace professional clinical diagnosis, nor can it be used as a basis for diagnosis alone, it has a significant screening effect on minor mental health problems.
Europe health-related quality of life questionnaire 5 dimensions (EQ-5D)
Time frame: 7minutes
Europe health-related quality of life questionnaire 5 dimensions (EQ-5D) is a preference-based health life quality measurement tool. It includes 5 self-classifier questions and 0 - Two parts including a 100-point self-assessment scale for current health status.
The headache diary
Time frame: 20minutes
The headache diary is to record your own headache diary every day, which can make it easier to communicate with the doctor about your pain condition and help the doctor treat primary headaches.
Migraine Disability Assessment Questionnaire (MIDAs)
Time frame: 7minutes
Migraine Disability Assessment Questionnaire (MIDAs) In 1999, Stewart and Lipton proposed the Migraine Disability Assessment Questionnaire (MIDAs). This scale mainly consists of five questions, asking the patient to recall the impact of migraine on schoolwork or work, household affairs, and family, social or leisure activities during the past three months. This questionnaire is also used in Japan, Upper Turkey, Italy and other countries because it is simple and easy to use and has good reliability, validity and objectivity evaluation.
The Taiwan Short Form 36 Health Scale (SF-36)
Time frame: 20minutes
The Taiwan Short Form 36 Health Scale (SF-36) is a widely used health-related quality of life questionnaire and is also used by people with different cultural backgrounds. Research results show that SF36 has been proven to have good reliability and validity regardless of the diagnosis, age, and gender of the test subjects, and it can also sensitively detect changes before and after treatment without falling. Therefore, this study uses SF36 as the outcome measurement tool for this study.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chien-Chung YANG study director
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Real acupuncture in people with Headache Migraine, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chien-Chung YANG (03-3196200 ext. 2610, r55161@cgmh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numerical rating scale (time frame: 2 minutes). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2024.